Transmagnetic Stimulation Pilot in Early Stage Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

A Single Arm Study of Resting State Functional Magnetic Resonance Imaging (Rs-fMRI)-Guided Theta Burst Stimulation (TBS) in Early-Stage Alzheimer's Disease (AD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05292222
• Other study ID #: A21-251
• Status: Completed
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: November 7, 2023

Study information

• Verified date: November 2023
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Alzheimer's disease (AD) is a progressive neurodegenerative condition affecting 6.2 million individuals in the United States, resulting in an annual cost of care of $305 billion. AD is functionally characterized by progressive degeneration of large-scale brain networks (LSBNs), including the default mode network (DMN) presumably from the deposition of amyloid plaques and neurofibrillary tangles. Available FDA-approved medications for AD such as donepezil and memantine offer limited benefit and modest impact on quality of life. In combination with resting state functional MRI (rs-fMRI), transcranial magnetic stimulation (TMS) with intermittent theta burst stimulation (iTBS) offers a non-invasive alternative to pharmacotherapy in persons with AD. We propose a pilot trial using rs-fMRI to target dysfunctional LSBNs in early stage AD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 7, 2023
• Est. primary completion date: November 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• Established diagnosis of Mild Cognitive Impairment (MCI)/mild AD

• Evidence for Central Nervous System (CNS) amyloidosis (e.g., Amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) biomarkers consistent with AD)

• Prior brain imaging performed

• Mini-Mental State Examination (MMSE) >24

• Clinical Dementia Rating (CDR) Scale 0.5-1

• Stable dose of cholinesterase inhibitors and memantine for at least one month

• Subjects are between 40-90 years of age

Exclusion Criteria:

• Non-AD dementia including, but not limited to, Lewy body dementia, frontotemporal dementia, vascular dementia, Jakob-Creutzfeldt disease, etc.

• Inability to tolerate rs-fMRI

• Contraindication of rs-fMRI due to implants or metal

• Seizure disorder

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Device:
• Intermittent theta burst stimulation
MagVenture TMS Therapy with theta burst stimulation. Resting motor threshold: 80%; Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz

Locations

Country	Name	City	State
United States	HealthPartners Neuroscience Center	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in connectivity measure of the TGd parcellations.	Assessed by calculating the difference and corresponding 95% confidence interval between follow-up and baseline connectivity measures of the TGd parcellations. Range: -1 to 1.; Positive values indicate areas where connectivity is higher than healthy controls from the Human Connectome Project.	9 weeks